Pyloric valve devices and methods

ABSTRACT

A pyloric valve is provided for inhibiting the flow of chyme through the pyloric region of the gastrointestinal tract. The pyloric valve includes a blocking portion having a disc-shaped inlet and a helical flange. The helical flange may be disposed in a contracted position defining a contracted length and a contracted diameter and an extended position defining an extended length and an extended diameter, wherein the extended length is longer than the contracted length and the extended diameter is smaller than the contracted diameter. The pyloric valve may further include a sleeve that may have a beveled distal end. The pyloric valve may be constructed of silicon. Also provided are methods of inserting and removing the pyloric valve, which each include a step of manipulating the support between its contracted and extended positions. Insertion and removal systems are also provided for use with the pyloric valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the filing dates of U.S.Provisional Patent Application No. 61/123,472 filed Apr. 9, 2008, andentitled PYLORIC VALVE, and U.S. Provisional Patent Application No.61/206,048 filed Jan. 27, 2009, and entitled PYLORIC VALVE DEVICES ANDMETHODS, the disclosures of which are hereby incorporated herein byreference.

FIELD OF THE TECHNOLOGY

The present invention relates to devices and methods of implanting thedevices in the gastrointestinal (“GI”) tract to aid in controllingobesity, and more particularly to pyloric valves and methods ofimplanting the pyloric valves in the pyloric region of the stomach tocontrol the flow of chyme through the stomach.

BACKGROUND OF THE INVENTION

Obesity is a condition in which the natural energy reserve, stored inthe fatty tissue of humans and other mammals, is increased to a pointwhere it is associated with certain adverse health conditions. Althoughobesity is an individual clinical condition, it is increasingly viewedas a serious and growing public health problem. Excessive body weighthas been shown to be a predisposition to various diseases, particularlycardiovascular diseases, diabetes mellitus type 2, sleep apnea andosteoarthritis.

The main treatment for obesity is to reduce body fat by ingesting fewercalories and increasing exercise. A beneficial side effect of exerciseis to increase muscle, tendon, and ligament strength, which helps toprevent injury from accidents and vigorous activity. Diet and exerciseprograms produce an average weight loss of approximately 8% of totalbody mass (excluding results from those individuals who drop out of suchprograms). Not all dieters are satisfied with these results, but a lossof as little as 5% of body mass can create large health benefits. Muchmore difficult than reducing body fat is maintaining its absence. Eightyto ninety-five percent of those who lose 10% or more of their body massthrough dieting regain their lost body mass within two to five years.

The body has systems that maintain its homeostasis, including bodyweight, at certain set points. Therefore, keeping weight off generallyrequires making exercise and healthy eating a permanent part of aperson's lifestyle. Certain nutrients or chemicals, such asphenylalanine, are natural appetite suppressants which allow the body toreset its set point with regard to body weight. However, dieting,exercise, and/or appetite suppressants may not result in sufficientweight loss in patients with serious medical conditions.

An alternative mechanism for hunger suppression might require decreasingthe rate of gastric emptying without the ingestion of chemicals in aneffort to regulate satiety. It should be understood that the effects ofregulating satiety may vary between individuals.

Partially undigested food in the GI tract is generally referred to aschyme. Satiety receptors are generally located all along the stomach. Ifchyme remains in the stomach for a longer period of time than itnaturally would before flowing into the small intestine, the satietyreceptors have a greater chance of being activated to signal thesensation of being satiated.

Therefore, a need exists for a device that is structured to inhibit therate that chyme passes through the GI tract while allowing naturalperistaltic action to occur. Such a device would, in effect, regulatesatiety and control body mass, and thus obesity, through itsimplantation in the GI tract. Also, such a device implanted in thestomach and/or small intestine would enhance the ability of anoverweight or obese patient to feel satiated so that the patient doesnot overeat, but rather eat less than normal.

There also exists a need for a novel method of implanting such a devicein the pyloric region of the GI tract. Generally, such a device wouldenter the GI tract endoscopically and would pass through an endoscope inan unexpanded or compressed form. After the device has passed throughthe endoscope and is implanted in the region, the device preferablywould expand to fit securely against tissue surrounding the region suchthat the position of the device is substantially maintained throughoutthe digestive process.

SUMMARY OF THE INVENTION

A first aspect of the present invention is a pyloric valve forinhibiting the flow of chyme through the pyloric region of thegastrointestinal tract comprising a blocking portion including at leastone axially-aligned annular flange defining a central opening and havingan outer circumference and a recess disposed in the outer circumference,and a support having a rim and a support surface, the rim beingconnected to the proximal-most of the at least one axially-alignedannular flange, the support having a nested position wherein the supportsurface is disposed within the central opening and an inverted positionwherein the support surface is disposed away from the central opening.

In accordance with certain embodiments of this first aspect, therecesses of the at least one axially-aligned annular flange may beaxially aligned. Each of the at least one axially-aligned annular flangemay be connected to another through at least one strut. The at least oneaxially-aligned annular flange may further include at least oneprojection extending radially from the outer circumference. The supportsurface may define a convexity. The convexity may be open toward theproximal direction when the support is in the nested position. Theconvexity may be open toward the distal direction when the support is inthe inverted position. The blocking portion and the support may togethercomprise a proximal portion, and the pyloric valve may further comprisean intermediate portion and a distal portion. The intermediate portionmay include at least one flexible column and a part-spherical portion.The at least one flexible column may be connected to the proximalportion. The part-spherical portion may connect the at least oneflexible column to the distal portion. The distal portion may include asleeve. The sleeve may include a tubular surface having one or moreapertures. The sleeve may include a beveled distal end. The pyloricvalve may be constructed of silicon.

In accordance with further embodiments of this first aspect, a kit maybe provided comprising the pyloric valve and an insertion systemincluding a gastroscope, a fluoroscope, a guidewire, a first tube, asecond tube larger in diameter than the first tube, and an over-tubelarger in diameter than the second tube. A kit may be providedcomprising the pyloric valve and a removal system including agastroscope, a fluoroscope, an over-tube, and at least one of a snare, agrasper, and a pair of scissors.

A second aspect of the present invention is a method of inserting apyloric valve for inhibiting the flow of chyme through the pyloricregion of the gastrointestinal tract comprising the steps of providing apyloric valve including a blocking portion and a support, the blockingportion having at least one axially-aligned annular flange defining acentral opening and having an outer circumference and a recess disposedin the outer circumference, the support having a rim and a supportsurface, the rim being connected to the proximal-most of the at leastone axially-aligned annular flange, the support having a nested positionwherein the support surface is disposed within the central opening andan inverted position wherein the support surface is disposed away fromthe central opening, inserting the pyloric valve through a patient'sesophagus and into the patient's stomach with the support in theinverted position, positioning the pyloric valve to a location adjacentto the patient's pyloric sphincter, and manipulating the support fromthe inverted position to the nested position.

In accordance with certain embodiments of this second aspect, thesupport surface may define a convexity, and the step of manipulating mayinclude manipulating the support such that the convexity is changed froman orientation where it is open toward the distal direction to anorientation where it is open toward the proximal direction. The step ofproviding a pyloric valve may further include the blocking portion beinga proximal portion, and the pyloric valve may further comprise anintermediate portion and a distal portion, the intermediate portionincluding at least one flexible column, and the distal portion includinga sleeve, wherein the step of positioning may include positioning theintermediate portion substantially within the pyloric sphincter of thepatient. The step of manipulating may include using a pulley systemhaving a suture.

A third aspect of the present invention is a pyloric valve forinhibiting the flow of chyme through the pyloric region of thegastrointestinal tract comprising a blocking portion including aplurality of disc-shaped flanges connected in series, each of theplurality of disc-shaped flanges having an outer circumference and arecess disposed in the outer circumference, the blocking portion havinga contracted position wherein the plurality of disc-shaped flanges isdisposed in a stacked configuration and a resting position wherein theplurality of disc-shaped flanges is disposed in a linear configuration.

In accordance with certain embodiments of this third aspect, therecesses of the plurality of disc-shaped flanges may be axially alignedwhen the blocking portion is in the contracted position. Any one or moreof the plurality of disc-shaped flanges may further include at least oneprojection extending radially from the outer circumference. The blockingportion may be a proximal portion, and the pyloric valve may furthercomprise an intermediate portion and a distal portion, the intermediateportion including at least one flexible column and a part-sphericalportion, the at least one flexible column being connected to theproximal portion, and the part-spherical portion connecting the at leastone flexible column to the distal portion. The distal portion mayinclude a sleeve. The sleeve may include a tubular surface having one ormore apertures. The sleeve may include a beveled distal end. The pyloricvalve may be constructed of silicon.

In accordance with further embodiments of this third aspect, a kit maybe provided comprising the pyloric valve and an insertion systemincluding a gastroscope, a fluoroscope, a guidewire, a first tube, asecond tube larger in diameter than the first tube, and an over-tubelarger in diameter than the second tube. A kit may be providedcomprising the pyloric valve and a removal system including agastroscope, a fluoroscope, an over-tube, and at least one of a snare, agrasper, and a pair of scissors.

A fourth aspect of the present invention is a method of inserting apyloric valve for inhibiting the flow of chyme through the pyloricregion of the gastrointestinal tract comprising the steps of providing apyloric valve including a blocking portion having a plurality ofdisc-shaped flanges connected in series, each of the plurality ofdisc-shaped flanges having an outer circumference and a recess disposedin the outer circumference, the blocking portion having a contractedposition wherein the plurality of disc-shaped flanges is disposed in astacked configuration and a resting position wherein the plurality ofdisc-shaped flanges is disposed in a linear configuration, inserting thepyloric valve through a patient's esophagus and into the patient'sstomach with the blocking portion in the resting position, positioningthe pyloric valve within the patient's pyloric sphincter, andmanipulating the blocking portion from the resting position to thecontracted position.

In accordance with certain embodiments of this fourth aspect, the stepof providing a pyloric valve may further include the blocking portionbeing a proximal portion, and the pyloric valve may further comprise anintermediate portion and a distal portion, the intermediate portionincluding at least one flexible column, the distal portion including asleeve, wherein the step of positioning may include positioning theintermediate portion substantially within the pyloric sphincter of thepatient. Each of the plurality of disc-shaped flanges may furtherinclude a central aperture and a suture threaded through each successiveaperture, and the step of manipulating may further include stacking theplurality of disc-shaped flanges in the contracted position by slidingat least one of the plurality of disc-shaped flanges distally along thesuture.

A fifth aspect of the present invention is a pyloric valve forinhibiting the flow of chyme through the pyloric region of thegastrointestinal tract comprising a blocking portion including adisc-shaped inlet and a helical flange, the disc-shaped inlet having anouter circumference and a recess disposed in the outer circumference,and the helical flange extending along a longitudinal axis and having anouter edge and at least one recess disposed in the outer edge, thehelical flange having a contracted position defining a contracted lengthand a contracted diameter and an extended position defining an extendedlength and an extended diameter, wherein the extended length is longerthan the contracted length and the extended diameter is smaller than thecontracted diameter.

In accordance with certain embodiments of this fifth aspect, therecesses of the disc-shaped inlet and the helical flange may be axiallyaligned when the helical flange is in the contracted position. Thedisc-shaped inlet may further include at least one projection extendingradially from the outer circumference. The blocking portion may be aproximal portion, and the pyloric valve may further comprise anintermediate portion and a distal portion, the intermediate portionincluding at least one flexible column and a part-spherical portion, theat least one flexible column being connected to the proximal portion,and the part-spherical portion connecting the at least one flexiblecolumn to the distal portion. The distal portion may include a sleeve.The sleeve may include a tubular surface having one or more apertures.The sleeve may include a beveled distal end. The pyloric valve may beconstructed of silicon.

In accordance with further embodiments of this fifth aspect, a kit maybe provided comprising the pyloric valve and an insertion systemincluding a gastroscope, a fluoroscope, a guidewire, a first tube, asecond tube larger in diameter than the first tube, and an over-tubelarger in diameter than the second tube. A kit may be providedcomprising the pyloric valve and a removal system including agastroscope, a fluoroscope, an over-tube, and at least one of a snare, agrasper, and a pair of scissors.

A sixth aspect of the present invention is a method of inserting apyloric valve for inhibiting the flow of chyme through the pyloricregion of the gastrointestinal tract comprising the steps of providing apyloric valve including a blocking portion having a disc-shaped inletand a helical flange, the disc-shaped inlet having an outercircumference and a recess disposed in the outer circumference, and thehelical flange extending along a longitudinal axis and having an outeredge and at least one recess disposed in the outer edge, the helicalflange having a contracted position defining a contracted length and acontracted diameter and an extended position defining an extended lengthand an extended diameter, wherein the extended length is longer than thecontracted length and the extended diameter is smaller than thecontracted diameter, inserting the pyloric valve through a patient'sesophagus and into the patient's stomach with the helical flange is inthe extended position, positioning the pyloric valve within thepatient's pyloric sphincter, and manipulating the helical flange fromthe extended position to the contracted position.

In accordance with certain embodiments of this sixth aspect, the step ofproviding a pyloric valve may further include the blocking portion beinga proximal portion, the pyloric valve may further comprise anintermediate portion and a distal portion, the intermediate portionincluding at least one flexible column, the distal portion including asleeve, and the step of positioning includes positioning theintermediate portion substantially within the pyloric sphincter of thepatient. The step of manipulating may include forcing the disc-shapedinlet against the helical flange.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the subject matter of the presentinvention and the various advantages thereof can be realized byreference to the following detailed description in which reference ismade to the accompanying drawings in which:

FIG. 1 is a view of a portion of a normal GI tract of a human.

FIG. 2 is a perspective view of a “top hat” style implant in accordancewith an embodiment of the present invention.

FIG. 3 is a perspective view of a pulley system utilized with theproximal end of the implant shown in FIG. 2.

FIG. 4 is a perspective view of a “top hat” style implant according toanother embodiment of the present invention.

FIG. 5 is a perspective view of a proximal end of the implant shown inFIG. 4.

FIG. 6 is a sectional view of the implant shown in FIG. 4.

FIG. 7 is a perspective view of an “accordion” style implant accordingto another embodiment of the present invention.

FIGS. 8 and 9 are perspective views of the flanges of the implant shownin FIG. 7 in a contracted position and a resting position, respectively.

FIG. 10 is a perspective view of a “spiral” style implant according toanother embodiment of the present invention.

FIG. 11 is another perspective view of the implant shown in FIG. 10.

FIG. 12 is a perspective view of a proximal end of the implant shown inFIG. 10.

FIG. 13 is a sectional view of the implant shown in FIG. 10.

FIG. 14 is a close-up sectional view of the proximal end of the implantshown in FIG. 10.

FIG. 15 is another perspective view of the implant shown in FIG. 10.

FIG. 16 is a sectional view of the implant shown in FIG. 10.

FIG. 17 is an implant of the present invention inserted in the GI tractof a patient.

FIG. 18 is a gastroscope positioned through the esophagus of a patientwith its distal end positioned adjacent to a pyloric sphincter.

FIG. 19 is a guidewire positioned through the gastroscope shown in FIG.18.

FIG. 20 is the guidewire shown in FIG. 19 properly positioned within thepatient.

FIG. 21 is a “top hat” style implant in a nested position.

FIG. 22 is the implant shown in FIG. 21 in an inverted position.

FIG. 23 is view of the guidewire being threaded through the implantshown in FIG. 22.

FIG. 24 is close-up sectional view of the guidewire being threadedthrough the distal end of the implant shown in FIG. 22.

FIG. 25 is the implant shown in FIG. 21 being positioned in thepatient's stomach.

FIG. 26 is an over-tube being positioned through the esophagus andadjacent the implant shown in FIG. 21.

FIG. 27 is a step in process of actuating the implant shown in FIG. 21from its inverted position to its nested position using a pulley system.

FIG. 27 a is close-up view of the step shown in FIG. 27.

FIG. 28 is the removal of the pulley system shown in FIG. 27.

FIG. 28 a is close-up view of the step shown in FIG. 28.

FIG. 29 is a step in the process of removing insertion equipment fromthe patient.

FIG. 29 a is close-up view of the step shown in FIG. 29.

FIG. 30 is another step in the process of removing insertion equipmentfrom the patient.

FIG. 30 a is close-up view of the step shown in FIG. 30.

FIG. 31 is yet another step in the process of removing insertionequipment from the patient.

FIG. 31 a is close-up view of the step shown in FIG. 31.

FIG. 32 is still another step in the process of removing insertionequipment from the patient.

FIG. 32 a is close-up view of the step shown in FIG. 32.

FIG. 33 is another step in the process of removing insertion equipmentfrom the patient.

FIG. 33 a is close-up view of the step shown in FIG. 33.

FIG. 34 is yet another step in the process of removing insertionequipment from the patient.

FIG. 34 a is close-up view of the step shown in FIG. 34.

FIG. 35 is the insertion of the gastroscope to check the properpositioning of the implant shown in FIG. 21.

FIG. 36 is the implant shown in FIG. 21 located adjacent the pyloricsphincter.

FIG. 37 is a step in the process of removing the implant shown in FIG.21 from the patient.

FIG. 38 is the process of actuating the implant shown in FIG. 21 from anested position to an inverted position.

FIG. 39 is the implant shown in FIG. 21 actuated into its invertedposition.

FIG. 40 is the removal of the implant shown in FIG. 21 from thepatient's esophagus.

DETAILED DESCRIPTION

As used herein, when referring to parts of the body, the term “proximal”means closer to the heart and the term “distal” means more distant fromthe heart. The term “inferior” means lower or bottom and the term“superior” means upper or top. The term “anterior” means towards thefront part of the body or the face and the term “posterior” meanstowards the back of the body. The term “medial” means toward the midlineof the body and the term “lateral” means away from the midline of thebody.

Referring to the drawings, wherein like reference numerals refer to likeelements, there is shown in FIG. 1 an example of a portion of a GI tract10 of a human body. Two smooth muscle valves, or sphincters, contain thecontents of the stomach within the stomach upon ingestion. They are theesophageal sphincter (not shown), found in the cardiac region above theantrum cardiacum, and the pyloric sphincter 20, disposed between thestomach 30 and the small intestine 40. Pyloric sphincter 20 is a strongring of smooth muscle at the end of the pyloric canal that functions tohelp regulate the passage of chyme from stomach 30 to the duodenum 50.As shown in FIG. 1, the pyloric antrum 60 is located between stomach 30and pyloric sphincter 20, or it can be said that pyloric antrum 60 islocated proximally of pyloric sphincter 20. Therefore, duodenum 50 islocated distally of pyloric sphincter 20.

Satiety receptors 80 are generally located all along the inside liningof stomach tissue. Partially undigested food in GI tract 10 is generallyreferred to as chyme. If chyme remains in the region of the stomachbefore flowing into small intestine 40, satiety receptors 80 have agreater chance of being activated, which enhances the ability of anoverweight or obese patient to feel satiated and suppresses the desireto eat.

A pyloric valve or implant according to any of the below-describedembodiments is preferably comprised of a polymeric structure that iscompliant and generally flexible and bendable. Preferably, at least aportion of the implant is made of silicone. Some portions of the implantmay be thicker than others for enhanced strength properties and toenhance the capability of the implant to resist the natural peristalticaction of GI tract 10. Alternatively, some portions of the implant maybe thinner than others to allow for the material peristaltic actions ofGI tract 10 to occur without the implant providing a counteractiveforce. Preferably, if a portion of the implant is bent or twisted duringinsertion, its polymeric structure will allow it to revert back to itsresting or initial shape.

The one or more materials that comprise an implant according to thepresent invention are preferably selected for their ability to yield andflex during implantation and removal of the implant. These propertiesalso protect the patient and the tissues and organs with which theimplant comes into contact. The compliant nature of the implant allowsits configuration to be manipulated during a surgical procedure,preferably in such a way that the implant tends to revert to its initialconfiguration. The implant may be made of shape memory material, such asnitinol or other known pliable polymeric materials, to allow forexpansion back into its initial configuration. Any or all of the implantmay be coated with Teflon to provide a smooth outer surface to reducefriction between the implant and the patient during implantation andremoval.

An implant according to the present invention is structured to inhibitthe rate that chyme passes through GI tract 10, thereby enhancing theability of chyme to activate satiety receptors 80 and effectivelyenhance satiety in a patient. The implant is also preferably structuredto reduce absorption. In particular, the implant is preferablystructured to reduce the rate of gastric emptying such that obesity canbe controlled by controlling satiety.

Certain components of an implant according to the present invention maybe discussed as being attached or connected to one another. Preferably,the implant is constructed of one continuous piece and of one material,preferably silicone. However, two or more components of the implant maybe manufactured separately and subsequently assembled. If assembled,components may be glued together using a silicone-based glue.

Preferably, an implant according to the present invention is configuredto have a lesser or collapsed diameter during implantation and removal,and may expand to conform to the organs with which the implant comesinto contact during and after implantation. These features are desirablefor all components of the implant, whether manufactured together orseparately.

Insertion and removal of an implant according to the present inventionmay require certain surgical tools. An insertion system 55 associatedwith the implant may include a guidewire 84, preferably of at leastabout 240 centimeters in length and preferably about 0.035 inches indiameter, at least one tube including a small tube 86, a medium tube 91,and an over-tube 88, and at least one device to aid in holding, pushing,or pulling the tubes, such as a handle. Preferably, small tube 86includes a small tube handle 94 and medium tube 91 includes a mediumtube handle 73. Small tube handle 94 and medium tube handle 73 may beconnectable to form a single handle.

A removal system 65 associated with the implant may include a snare 98,a grasper 99, and a pair of scissors 90, which may be, for example,Olympus Scissors with a working length of approximately 165 centimetersand a channel size of approximately 2.8 millimeters, for example.Implantation and/or removal may further be aided by a fluoroscope 96and/or a gastroscope 82. Gastroscope 82 is preferably approximately 9.8millimeters in length, and preferably has approximately a 2.8 millimeterworking channel and suitable viewing and recording equipment, forexample. It will be understood that tools and components that aredescribed as being passed through or inserted into gastroscope 82 arepassed through or inserted into its working channel. A lubricant such asSurgilube or equivalent may be provided as needed to lubricate theimplant and/or any of the associated surgical equipment.

The following is a description of a “top hat” style implant. FIG. 2depicts implant 100, which includes a sleeve 102, a duodenal sphere 107,at least one pyloric column 108, at least one axially-aligned annularflange 109, and a top portion 106. Sleeve 102 may be manufactured to anylength according to a particular patient and/or surgical procedure, andincludes at its distal end a beveled tip 101. Along its length, sleeve102 may have one or more side holes 132 (not shown) which providefurther access for chyme to enter sleeve 102.

Sleeve 102 is generally disposed along a longitudinal axis 122 ofimplant 100. A rib 131 is disposed along sleeve 102 and is preferablysubstantially parallel to longitudinal axis 122, though rib 131 mayextend only partially along sleeve 102 and may take on a curved or othertype of orientation with respect to longitudinal axis 122. Rib 131 maybe comprised of silicone and additionally may include a radiopaquematerial, such as barium, so that rib 131 may be detected by fluoroscope96. Rib 131 may be provided as a separate component and later attachedto sleeve 102, or rib 131 may essentially be the overlapping seam formedduring the manufacture of sleeve 102 when a flat piece of material isrolled into a tubular shape. In such a configuration, sleeve 102 may becomprised of a homogenous material attached by a radiopaque glue. Ofcourse, as rib 131 is primarily used as an aid during implantationand/or removal of implant 100, rib 131 need not necessarily be includedin this or any other embodiment according to the present invention.

Located on sleeve 102 adjacent to beveled tip 101 is a hole 103 that ispreferably of a smaller diameter than the outer diameter of small tube86. Small tube 86 is utilized in order to maintain the length of sleeve102 by extending small tube 86 through sleeve 102 up to and against hole103. Small tube 86 is otherwise too flimsy to translate a push forcefrom the surgeon to implant 100.

Sleeve 102 is connected at its proximal end to duodenal sphere 107,which may include at least one slot 110 to enhance its flexibilityand/or to provide additional means for the passage of chyme into sleeve102. Slot 110 is angled with respect to a longitudinal axis 122 ofimplant 100, though any orientation of slot 110 with respect tolongitudinal axis 122 would suffice. Slot 110 may also be shaped as anyother geometrical figure, such as a circle, ellipse, quadrilateral, etc.Although more clearly shown in FIGS. 4-6 with respect to an implant 200,duodenal sphere 107 includes a boss 138 which is disposed within sleeve102. Boss 138 is connected to sleeve either integrally or throughbonding, and includes a passage 139 oriented along an axis that ispreferably substantially parallel to longitudinal axis 122. Passage 139preferably has an internal diameter greater than the external diameterof small tube 86, but smaller than the external diameter of medium tube91.

Attached to the proximal end of duodenal sphere 107 is the at least onepyloric column 108, which may be cylindrical or any other type ofprismic shape. Preferably, implant 100 includes three or more pyloriccolumns 108, which are attached to the at least one flange 109, orblocking member, through a button 133. Button 133 is preferablycomprised of a material having a greater rigidity than the rest ofimplant 100, and may either be co-molded into implant 100 or assembledafterward as a separately manufactured component. Button 133 isconfigured similarly to a conventional button, being disc-shaped andhaving two or more bores 134 (not shown). Button 133 may be disposedwithin or adjacent to the distal-most flange 109.

Each flange 109 is substantially annularly shaped and defines an outercircumference and a central opening or hole. When two or more flanges109 are provided, such may be connected by at least one strut 105.Struts 105 may, as depicted, be aligned to form a more formidableconnection between flanges 109. It is also contemplated that struts 105may be spaced circumferentially about each flange 109 such that they arenot necessarily aligned along any axis parallel to longitudinal axis 122of implant 100. Flanges 109 may have identical or varying outerdiameters, and due to their composition, may flex and bend duringpositioning of implant 100 in stomach 20. Flanges 109 may also bend orflex due to natural peristaltic action of stomach 20 during contact withsurrounding stomach tissue. It should be understood by one of ordinaryskill in the art that flanges 109 may be of any configuration thatallows flanges 109 to be connected to one another in a generallyparallel and stacked configuration while allowing implant 100 to bepositioned as described below. Each of flanges 109 includes a recess 114which is preferably aligned along a recess axis 135 that is preferablysubstantially parallel to longitudinal axis 122, though recesses 114need not be aligned in a parallel manner. Recesses 114 are configured toallow a tube, such as small tube 86 and/or medium tube 91, to passtherethrough and along flanges 109 without substantially changing thediametric size of implant 100 during insertion and removal.

Top portion 106, which is a support, includes a narrow end 112 and aninlet 111, which is essentially the proximal-most flange. Inlet 111 issubstantially annular with an outer diameter that may be greater thanthat of any other flange 109. Narrow end 112, which is a supportsurface, connects with inlet 111 at an inner rim 113. Narrow end 112 maybe manipulated to be disposed either distally of inlet 111 within thecentral openings of flanges 109 (as shown) or proximally of inlet 111and away from the central openings of flanges 109, such that top portion106 is in a nested or inverted position, respectively. The nestedposition is essentially a mirror image of the inverted position, withthe plane of symmetry being essentially inlet 111. Stated another way,the narrow end 112, or support surface, is of a convex nature, whereinthe open portion, or convexity, is open toward the proximal directionwhen the support is in the nested position. Similarly, the convexity ofthe narrow end 112, or the support surface, is open toward the distaldirection when the support is in the inverted position.

Top portion 106 is included to provide reinforcement to the at least oneflange 109. While implant 100 is comprised of a material that flexes andbends during implantation and removal, a more rigid composition isdesired after implantation such that implant 100 will maintain itsimplanted position and thus properly reduce the flow of chyme through GItract 10. Therefore, when top portion 106 is disposed in its nestedposition, it supports and provides a “backbone” for flanges 109. Theinverted position of top portion 106 is thusly advantageous forimplantation and removal in that implant 100 is in a more flexible stateso as to yield more willingly to the patient's body tissue. Top portion106 may be actuated between its nested and inverted positions fromeither outside or within the patient.

As flanges 109 act to control or inhibit the flow of chyme betweenstomach 30 and duodenum 50, the flow of gasses and other stomach fluidsis similarly inhibited. Along with the normal peristaltic action of thesurrounding tissue, such gasses may cause a buildup of pressure that maytend to force implant 100 in a distal or proximal direction. Recesses114 aid in relieving such pressure between stomach 30 and duodenum 50when implant 100 is fully inserted by allowing such gasses to passthrough recesses 114. It is contemplated that recesses 114 may bestaggered circumferentially about flanges 109 without compromising theability of recesses 114 to reduce pressure.

Another embodiment of implant 100 is depicted in FIGS. 4-6 as implant200, with like elements referenced by like numbers. Inlet 211 of topportion 206 includes at least one projection 215 spacedcircumferentially about its outer diameter. Projections 215 may aid inassembly of implant 200, and may be removed prior to insertion. Slots210 of duodenal sleeve 207 are substantially parallel to longitudinalaxis 222 of implant 200, as opposed to being slanted with respectthereto, as in implant 100. Narrow end 212 is more clearly shown toinclude an aperture 216 and an extension 217. Aperture 216 is disposedat the end of narrow end 212 opposite inlet 211. Extension 217 iscylindrically shaped and extends proximally from narrow end 212.Aperture 216 and extension 217 form a continuous through hole.

With reference to implant 100 and as shown in FIG. 3, a pulley system 72is utilized to actuate or manipulate top portion 106 between its nestedand inverted positions. It will be understood that in FIG. 3, certainelements are exaggerated in size and certain others are omitted forclarity. Pulley system 72 preferably includes a bead 79, a bead suture71, a gripping suture 78, a sheath 74, and a grip 76. Bead suture 71includes a first end 67 attached to bead 79, and a second end 68 thatextends through bead 79 such that bead 79 is slidable along bead suture71. Bead 79 is disposed proximally of aperture 116 and is dimensionednot to allow for passage therethrough. Second end 68 of bead suture 71forms a loop 66 which is tied to the adjacent bead suture 71 to form abead suture knot 64, which is disposed proximally of bead 68 anddimensioned not to allow for passage therethrough. Bead suture knot 64is preferably substantially anchored along bead suture 71.

With respect to implant 100, bead suture 71 is threaded distally throughone bore 134 of button 133 and then proximally through another bore 134of button 133. Both first end 67 and second end 68 extend proximallythrough aperture 116. Therefore, when second end 68 of bead suture 71 ispulled proximally, first end 67, and thus bead 79, is moved distally.Likewise, when either first end 67 or bead 79 is pulled proximally,second end 68 is moved distally. Button 133 thusly allows bead suture 71to act as a pulley.

Gripping suture 78 includes a first end 75 and a second end 77, and isdisposed through loop 66 of bead suture 71. First end 75 and second end77 each extend proximally from loop 66 and through sheath 74, whichextends from a point proximal of loop 66 to the exterior of thepatient's mouth 70. First end 75 and second end 77 each extendproximally from sheath 74. One of first end 75 and second end 77 passesthrough grip 76 and is tied to the other to form a gripping suture knot69 that is preferably substantially anchored at a point along grippingsuture 78. Gripping suture knot 69 is preferably dimensioned such thatit may be disposed within sheath 74.

Implant 100 is preferably manufactured and provided for insertion withtop portion 106 in its inverted position, but may alternatively beprepared for insertion by way of an actuation suture 104 (shown in FIG.3) threaded through aperture 116. Actuation suture 104 includes aproximal anchor 136 and a distal anchor 137 located proximally anddistally, respectively, of aperture 116 along actuation suture 104. Bothproximal anchor 136 and distal anchor 137 are dimensioned not to allowfor passage through aperture 116. If top portion 106 is in the nestedposition prior to insertion, actuation suture 104 may be pulledproximally, whereby distal anchor 137 contacts top portion 106 adjacentaperture 116 and manipulates top portion 106 into its inverted position,as shown in FIGS. 21-22 with reference to a similar implant 300 havinglike elements to those described above with respect to implants 100 and200. Actuation suture 104 is preferably relatively short compared to thelength of top portion 106 and may either be removed or may remain afterimplantation of implant 100.

Implant 100 is also preferably provided for insertion preassembled withthe necessary insertion tools and instruments. Small tube 86 ispreferably threaded along the at least one recess 114, between two ofthe pyloric columns 108, through duodenal sphere 107, through passage139 in boss 138, and finally into sleeve 102. Passage 139 should beconfigured such that small tube 86 encounters friction therewithin, anda force is required to insert and/or remove small tube 86 from passage139 which is greater than the forces that will generally be encounteredduring implantation and removal from the surrounding tissue. This helpssmall tube 86 to be stabilized within implant 100 in a proximal-distaldirection. In this position, distal end 87 of small tube 86 is disposedadjacent to hole 103, as shown in FIG. 23. Small tube 86 may not bepassed through hole 103, as the diameter of hole 103 is smaller than theouter diameter of small tube 86. Small tube 86 should be flexible, yetrigid enough to provide sleeve 102 with a “backbone” during theinsertion of implant 100. As implant 100 and sleeve 102 are designed tobe flexible in nature, small tube 86 is relatively less flexible andhelps sleeve 102, and for that matter, the proximally-located componentsof implant 100, to substantially maintain its proximal-distal lengthduring implantation.

Further in the preassembly, medium tube 91 is preferably threaded overand along small tube 86. Therefore, medium tube 91 is passed along theat least one recess 114, between two of the pyloric columns 108, throughduodenal sphere 107, and up to the proximal end of passage 139. A distalend 95 of medium tube 91, having an outer diameter larger than the innerdiameter of passage 139, is thusly disposed against boss 138 adjacent topassage 139 and may not be passed through passage 139. Small tube handle94 and medium tube handle 73 are preferably connected, though such aconnection is not necessary or required. As shown in FIG. 23, guidewire84 is inserted through hole 103 and a distal end 87 of small tube 86,and advanced proximally through the full length of small tube 86 untilguidewire 84 exits a proximal end 85 thereof and small tube handle 94.

The following describes a method of inserting a “top hat” style implant.FIGS. 18-40 depict a method of inserting an implant 300, having likeelements to those described above with respect to implants 100 and 200.Implant 300 enters and exits the patient through esophagus 92 and isultimately positioned in its operative state, wherein the at least onepyloric column 308 is adjacent to pyloric sphincter 20.

Initially, gastroscope 82 is lubricated, inserted into patient's mouth70, and fed through esophagus 92 and the gastroesophageal (“GE”)junction 35 into stomach 30, as shown in FIG. 18. Gastroscope 82 shouldultimately be positioned such that its distal end is adjacent to pyloricsphincter 20. Preferably, a hydrophilic coating of guidewire 84 ishydrated and inserted through gastroscope 82, as shown in FIG. 19.Guidewire 84 is passed through pyloric sphincter 20, which may be aidedby manipulation of gastroscope 82. It may also be beneficial to pass adistal end 83 of gastroscope 82 through pyloric sphincter 20 in order tomaneuver guidewire 84 through same. There should preferably be at leastabout 30-40 centimeters of the length of guidewire 84 passed distallythrough pyloric sphincter 20 and into small intestine 40 so that anyfurther movement of guidewire 84 during the insertion procedure does notresult in the accidental removal of the distal end of guidewire 84 to aposition proximal of pyloric sphincter 20. Of course, the length ofguidewire 84 that should preferably be passed distally through pyloricsphincter 20 may vary according to different patients and/or proceduresand may be less or more than 30-40 centimeters. After guidewire 84 isappropriately positioned, gastroscope 82 is removed from the patient.Fluoroscope 96 may then be used to check the positioning of guidewire84, which should be situated as shown in FIG. 20.

With implant 300 is in its inverted position, implant 300 is thoroughlylubricated. Implant 300, small tube 86, and medium tube 91 are moveddistally along guidewire 84 until implant 300 is positioned to beadvanced down esophagus 92. Again, it is noted that during thisprocedure care must be taken not to pull guidewire 84 proximally out ofsmall intestine 40.

As shown in FIG. 25, implant 300 is inserted through esophagus 92 andinto stomach 30 by pushing proximal end 97 of medium tube 91, whichpreferably includes medium tube handle 73. When implant 300 is disposedwithin the patient, medium tube 91 translates the insertion forceapplied by the surgeon. Because medium tube 91 is not able to passthrough passage 339, distal pressure applied to medium tube 91 thuslytranslates into movement of implant 300. It should be understood thatmedium tube 91 should be flexible, yet rigid enough that a force appliedto a proximal end 97 thereof may be effectively translated to distal end95 thereof without buckling medium tube 91. Although medium tube handle73 is available for manipulation, the surgeon may choose to additionallygrasp medium tube 91 at a varying position along its length that isclose to patient's mouth 70 during insertion.

Due to the length of implant 300, it is likely that at least part ofsleeve 302 will be passed through pyloric sphincter 20 prior to theentirety of implant 300 being disposed within stomach 30. Further,because of the size of implant 300, gastroscope 82 may be reinsertedinto stomach 30 after implant 300 is inserted. During insertion, itshould be ensured that any of the above-mentioned sutures do not becometangled, and that the proximal-most portion of gripping suture 78 enddoes not pass distally through mouth 70.

Over-tube 88 is preferably lubricated and inserted into the patient'smouth 70 and down esophagus 92 while being slid over small tube 86,medium tube 91, gastroscope 82, and any additional sutures and/orimplantation tools. It is conceivable that over-tube 88 be insertedprior to the insertion of implant 300, though such may require implant300 to be differently configured to fit within over-tube 88, which isnarrower than esophagus 92. Preferably, over-tube 88 is inserted toprotect esophagus 92, GE junction 35, and other internal bodily tissuefrom scarring when the various tubes and sutures are used duringimplantation, actuation, and removal of implant 300.

With implant 300 inserted such that pyloric columns 308 are adjacentpyloric sphincter 20 and top portion 306 is in its inverted position,distal end 81 of over-tube 88 is positioned in stomach 30 adjacent topportion 306. Because manipulation of top portion 306 into its nestedposition fortifies and substantially anchors implant 300 with respect tothe surrounding tissue, it is preferable that implant 300 be placed asclose to its final contracted position as possible prior to suchmanipulation.

As shown in FIGS. 3 and 27-28 a, pulley system 72 is actuated throughover-tube 88 to manipulate top portion 306 into its nested position.Grip 76 is pulled in a proximal direction, thusly pulling grippingsuture 78 and bead suture 71 by way of loop 66. As loop 66 and secondend 68 of bead suture 71 are pulled proximally, bead 79 is forceddistally along send end 68 of bead suture 71, contacts narrow portion312 of top portion 306, and forces top portion 306 into its nestedposition. Throughout this process, small tube 86 and/or medium tube 91may be held in position to prevent implant 300 from moving proximallywhen grip 76 is pulled.

After top portion 306 is in its nesting position, gripping suture 78 maybe disengaged from implant 300. Sheath may be moved slightly in a distaldirection with respect to gripping suture 78 in order to expose grippingsuture knot 69, as shown in FIGS. 27 and 27 a. Either first end 75 orsecond end 77 of gripping suture 78 is cut at a point distal of grippingsuture knot 69. Grip 76 is then pulled proximally, which pulls the uncutend of gripping suture 78 while the other end thereof travels distallythrough sheath 74 and loop 66 of bead suture 71, and passes proximallyfrom the patient. Sheath 74 may be removed either during or afterremoval of gripping suture 78. Over-tube 88 may then be removed, or mayalternatively be left in the patient during the subsequent checking ofimplant 300.

Although implant 300 should now be substantially in its final position,with pyloric columns 308 disposed within pyloric sphincter 20, mediumtube 91 may be used to further appropriately position implant 300.Gastroscope 82 and/or fluoroscope 96 may be used to confirm the finalplacement of implant 300. With implant 300 in its deployed state,guidewire 84, small tube 86, medium tube 91, and any other instrument ordevice may be gently pulled and removed from the patient. After alltools and devices have been removed, gastroscope 82 and/or fluoroscope96 may be used to inspect implant 300 to confirm correct assembly andlocation as shown in FIG. 36. Gastroscope 82, fluoroscope 96, andover-tube 88 may then be removed.

The following describes a method of removing a “top hat” style implant.Over-tube 88 is preferably lubricated and inserted through esophagus 92into stomach 30. Gastroscope 82 is preferably lubricated, insertedthrough over-tube 88, and preferably positioned such that its distal end83 is adjacent to top portion 306, as shown in FIG. 37. Snare 98 isinserted through gastroscope 82 and oriented around proximal anchor 336of actuation suture 304. Although snare 98 is preferred, forceps 93 (notshown), grasper 99 (not shown), or any other similar device may be usedfor removal of implant 300. Snare 98 is pulled proximally, therebypulling actuation suture 304 and forcing distal anchor 337 againstnarrow portion 312 of top portion 306. Top portion 306 is thuslymanipulated into its inverted position. If during this inversionprocess, top portion 306 does not invert, but rather implant 300 movesproximally out of pyloric sphincter 20, implant 300 should continue tobe pulled until it is disposed in the GE junction 35. The GE junction 35should provide sufficient resistance to allow for inversion of topportion 306. Once top portion 306 is in its inverted position,gastroscope 82, over-tube 88, and snare 98 (which maintains itsconnection with implant 300 via actuation suture 304) are preferablypulled from the patient all at once.

The following is a description of an “accordion” style implant. FIGS.7-9 depict implant 400, which is one embodiment of an “accordion” styleimplant. Implant 400 includes many similarities to the aforementioned“top hat” style implant, and like elements will be referenced by likenumerals. Implant 400 includes a sleeve 402, a duodenal sphere 407, atleast one pyloric column 408, and at least one disc-shaped flange 409.Each flange 409 is connected to each adjacent flange 409 through aconnector 418, such that the plurality of flanges 409 is connected inseries. Each flange 409 preferably includes an outer circumference witha recess 414 therein. Connectors 418 are preferably comprised of thesame material as the rest of implant 400, and thus are able to flex andbend. However, connectors 418 may also be comprised of a differentmaterial and grafted onto flanges 409.

Each flange 409 preferably includes one mound 419 and one hole 420. Asshown in FIGS. 7 and 9 when implant 400 is in a resting position, amound 419 is disposed on alternating proximal and distal sides ofsuccessive flanges 409. Flange 409 located closest to pyloric columns408 may not include a mound 419. Each mound 419 provides for spacingbetween adjacent flanges 409 when implant 400 is in a contractedposition, wherein the axis of each hole 420 is aligned. The contractedposition of implant 400 can be achieved by manipulating flanges 409 suchthat implant 400 closely resembles the configuration of implant 100wherein the plurality of disc-shaped flanges 409 is disposed in astacked configuration, as shown in FIG. 8. In its resting position,disc-shaped flanges 409 are disposed in a linear configuration, as shownin FIGS. 7 and 9. Of course, one difference between implant 100 andimplant 400 is that flanges 109 of implant 100 are connected by one ormore struts 105, whereas flanges 409 of implant 400 are connected by oneor more connectors 418. The result is that implant 400 in its contractedposition, from a proximal-to-distal direction, will have in successioninlet 411, mound 419, flange 409, mound 419, flange 409, mound 419, andso on until the distal-most flange 409 connects to pyloric columns 408.It is noted that certain elements, such as mounds 419 and recesses 414,are omitted from FIGS. 8 and 9 in order to more clearly depict therespective contracted and resting positions of implant 400.

The following describes a method of inserting an “accordion” styleimplant. The steps of the above-described method with respect to the“top hat” style implant are incorporated herein to the present method.Of course, certain aspects of the following method may differ as thevariations between the different embodiments of the implants are takeninto account. Implant 400 enters and exits the patient in its restingposition through esophagus 92, and is ultimately positioned in itsoperative state, wherein the at least one pyloric column 408 is adjacentto pyloric sphincter 20.

Initially, gastroscope 82 is lubricated, inserted into patient's mouth70, and fed through esophagus 92 and GE junction 35 into stomach 30.Gastroscope 82 should ultimately be positioned such that its distal endis adjacent to pyloric sphincter 20. Preferably, the hydrophilic coatingof guidewire 84 is hydrated and inserted through gastroscope 82.Guidewire 84 is passed through pyloric sphincter 20, which may be aidedby manipulation of gastroscope 82. It may also be beneficial to passdistal end 83 of gastroscope 82 through pyloric sphincter 20 in order tomaneuver guidewire 84 through same. There should preferably be at leastabout 30-40 centimeters of the length of guidewire 84 passed distallythrough pyloric sphincter 20 and into small intestine 40 so that anyfurther movement of guidewire 84 during the insertion procedure does notresult in the accidental removal of the distal end of guidewire 84 to aposition proximal of pyloric sphincter 20. Of course, the length ofguidewire 84 that should preferably be passed distally through pyloricsphincter 20 will vary according to different patients and/or proceduresand may be less or more than 30-40 centimeters. After guidewire 84 isappropriately positioned, gastroscope 82 is removed from the patient.Fluoroscope 96 may then be used to check the positioning of guidewire84.

As mentioned above, implant 400 should be preassembled with anynecessary implantation tools and instruments, of course taking intoaccount any differences in structure between the “top hat” and“accordion” styles of implants. Implant 400, while in its restingposition, is thoroughly lubricated. Implant 400, small tube 86, andmedium tube 91 are moved distally along guidewire 84 until implant 400is positioned to be advanced down esophagus 92. Again, it is noted thatduring this procedure care must be taken not to pull guidewire 84proximally out of small intestine 40.

Implant 400 is inserted through esophagus 92 and into stomach 30 bypushing proximal end 97 of medium tube 91, which preferably includesmedium tube handle 73. During insertion, flanges 409 trail the rest ofimplant 400. Hole 403 of implant 400 is smaller than the outer diameterof small tube 86. Because medium tube 91 is not able to pass throughpassage 439, distal pressure applied to medium tube 91 thusly translatesinto movement of implant 400. It should be understood that medium tube91 should be flexible, yet rigid enough that a force applied to proximalend 97 thereof may be effectively translated to distal end 95 thereofwithout buckling medium tube 91. Although medium tube handle 73 isavailable for manipulation, the surgeon may choose to additionally graspmedium tube 91 at a varying position along its length that is close topatient's mouth 70 during insertion.

The distal-most connector 418 may be bent to align flanges 409 with thedirection of insertion. Due to the length of implant 400 and theextended flanges 409, it is likely that at least part of sleeve 402 willbe passed through pyloric sphincter 20 prior to the entirety of implant400 being disposed within stomach 30. Further, because of the size ofimplant 400, gastroscope 82 may be reinserted into stomach 30 afterimplant 400 is inserted. During insertion, it should be ensured that anyof the above-mentioned sutures do not become tangled, and that theproximal-most portion of gripping suture 78 end does not pass distallythrough mouth 70.

With implant 400 inserted with flanges 409 in its resting position,over-tube 88 is preferably lubricated and inserted into the patient'smouth 70 and down esophagus 92 while being slid over small tube 86,medium tube 91, gastroscope 82, and any additional sutures and/orimplantation tools. Distal end 81 of over-tube 88 should preferably bepositioned in stomach 30 adjacent to the proximal-most flange 409.

An accordion suture 425, shown in FIG. 8, is disposed through hole 420on each flange 409, and includes a first end 442 and a second end 443. Afirst accordion bead 440 is attached to first end 442. Second end 443extends proximally from implant 400, while a second accordion bead 441is secured to accordion suture 425 between first end 442 and second end443. First accordion bead 440 is positioned distally of the distal-mostflange 409 and has a diameter such that it may not pass proximallythrough hole 420 of the distal-most flange 409. Prior to insertion,second accordion bead 441 is disposed proximally of the distal-mostflange 409 and distally of the next proximal flange 409. Secondaccordion bead 441 has a diameter that is slightly larger than thediameter of hole 420. The yielding nature of implant 400 will thuslyallow for the passage of second accordion bead 441 through each hole 420when a minimal force is applied.

Accordion suture 425 is preassembled as threaded through each successivehole 420 or aperture of each successive flange 409. To move implant 400into its contracted position, the surgeon preferably braces implant 400from proximal movement by holding medium tube 91. Accordion suture 425is preferably held from a position proximal of implant 400 so that itremains substantially taut. The surgeon then preferably pushes on theproximal-most flange 409 with a tube or pushing device (not shown). Sucha tube or pushing device may be a suture sheath 89, as depicted anddescribed more clearly below. The purpose of the tube or pushing deviceis to force flanges 409 distally such that they slide along accordionsuture 425. The tube or pushing device need not be adapted to bedisposed about accordion suture 425. As flanges 409 are pushed distally,second accordion bead 441 passes through each successive hole 420 offlanges 409 until flanges 409 are disposed in the contracted position,as shown in FIG. 8. Preferably, while flanges 409 are in the contractedposition, first accordion bead 440 is disposed to be in contact with thedistal side of the distal-most flange 409, while second accordion bead441 is disposed to be in contact with the proximal side of theproximal-most flange 409. As second accordion bead 441 passes througheach hole 420, the surgeon will encounter a tactile feel as secondaccordion bead 441 “pops” through each hole 420. Implant 400 will remainin its contracted position after the proximal force is released fromaccordion suture 425, which remains substantially taut and essentiallymaintains flanges 409 in the contracted position. Implant 400 is now inits fully assembled state. Gastroscope 82 and/or fluoroscope 96 may beused to inspect implant 400 to confirm that such is correctly assembled.Over-tube 88 may then be removed.

Although implant 400 should now be substantially in its final position,with pyloric columns 408 disposed within pyloric sphincter 20, mediumtube 91 may be used to further appropriately position implant 400.Gastroscope 82 and/or fluoroscope 96 may be used to confirm the finalplacement of implant 400. With implant 400 in its deployed state,guidewire 84, small tube 86, medium tube 91, and any other instrument ordevice may be gently pulled and removed from the patient. After alltools and devices have been removed, gastroscope 82 and/or fluoroscope96 may be used to inspect implant 400 and to confirm correct assemblyand location. Gastroscope 82, fluoroscope 96, and over-tube 88 may thenbe removed.

The following describes a method of removing an “accordion” styleimplant. The steps of the above-described method with respect to the“top hat” style implant are incorporated herein to the present method.Of course, certain aspects of the following method may differ as thevariations between the different embodiments of the implants are takeninto account. Over-tube 88 is preferably lubricated and inserted throughesophagus 92 into stomach 30. Gastroscope 82 is preferably lubricated,inserted through over-tube 88, and positioned such that its distal end83 is adjacent to the proximal end of implant 400. Forceps 93 areinserted through gastroscope 82 and positioned adjacent theproximal-most flange 409. The proximal-most flange 409 should be pulledproximally by forceps 93, thereby forcing second accordion bead 441distally through each hole 420 and returning flanges 409 to theirresting position. If during the removal process second accordion bead441 does not pass distally through any of holes 420, accordion suture425 may be cut with scissors 90 at a point distal to second accordionbead 441 and removed. Once flanges 409 are in their resting position,gastroscope 82, over-tube 88, and forceps 93 (which maintain theirconnection with implant 400 via accordion suture 425) are preferablypulled from the patient all at once.

The following is a description of a “spiral” style implant. FIGS. 10-16depict implant 500, which is one embodiment of a “spiral” style implant.Implant 500 includes many similarities to the aforementioned “top hat”and “accordion” style implants, and like elements will be referenced bylike numerals. Implant 500 includes a sleeve 502, a duodenal sphere 507,at least one pyloric column 508, a helical or spiral flange 509, and adisc-shaped inlet 511. Inlet 511 preferably includes an outercircumference and a recess 514 disposed in the outer circumference.Implant 500 further includes a first suture 523 having a knot 529 andbeing attached to a bead 530, a second suture 524 having a fore end 527and an aft end 528, and a plug 526. Plug 526 has the general externalappearance of a nail, and includes a thru-hole 546. Disposedcircumferentially about inlet 511 is a plurality of knobs 544. Ofcourse, implant 500 could be manufactured with only one knob 544 and theposition of same need not be adjacent to the perimeter of inlet 511.

Spiral flange 509 is a single unit that comprises a helically woundflange 509 extending along a longitudinal axis, and is similar in natureto the previously disclosed flanges 109, 209, 309, and 409. Due to thecomposition of spiral flange 509, it preferably includes a contractedposition defining a contracted length and a contracted diameter and anextended position defining an extended length and an extended diameter.The extended length is longer than the contracted length and theextended diameter is smaller than the contracted diameter. Thecontracted position can be seen, for example, in FIG. 11. Further, oneor more recesses 514 may be disposed in the outer edge of spiral flange509. Recess 514 in inlet 511 and recesses 514 in the outer edge ofspiral flange 509 may be axially aligned when spiral flange 509 is inthe contracted position. A suture sheath 89 is provided and preferablyincludes a suture sheath handle 63, which has a central passage 61 forfirst suture 523 and side passages 62 a, 62 b for fore end 527 and aftend 528 of section suture 524 to extend proximally. A pusher tube 59 isalso provided and preferably includes a pusher tube handle 58. Suturesheath 89 is preferably constructed to fit within pusher tube 59. Suturesheath handle 63 is connectable with pusher tube handle 58 to form asingle unit. As shown in FIG. 12, medium tube 91 includes anotherembodiment of a medium tube handle 73 a. Further shown in FIGS. 13 and14, medium tube 91 includes another embodiment of a medium tube handle73 b and small tube 86 includes another embodiment of a small tubehandle 94 b. Disposed about the proximal most portion of first suture523 is a grip 76 a.

As mentioned above, implant 500 should be preassembled with anynecessary implantation tools and instruments, of course taking intoaccount any differences in structure between the “top hat,” “accordion,”and “spiral” styles of implants. As part of the preassembly, firstsuture 523 is preferably disposed through spiral flange 509 andthru-hole 546 of plug 526 such that bead 530 is disposed distally ofboth spiral flange 509 and plug 526. Knot 529 should preferably also bedisposed distally of plug 526 but proximally of spiral flange 509 priorto insertion of implant 500. First suture 523 is preferably threadedproximally through a disc 547, suture sheath 89, and suture sheathhandle 63. Second suture 524 passes through two or more inlet holes 545of inlet 511 such that a fore end 527 and an aft end 528 of secondsuture 524 each extend proximally from implant 500. Pusher tube 59 ispreferably disposed about suture sheath 89. Proximal of suture sheathhandle 63, first suture 523 forms a loop, threads through grip 76 a, andconnects back to itself, preferably in a knot. It should be ensured thatfirst suture 523 and second suture 524 do not become tangled.

The following describes a method of inserting a “spiral” style implant.The steps of the above-described methods with respect to the “top hat”style and “accordion” style implants are incorporated herein to thepresent method. Of course, certain aspects of the following method maydiffer as the variations between the different embodiments of theimplants are taken into account. Implant 500 enters and exits thepatient through esophagus 92 and is ultimately positioned in itsoperative state, wherein the at least one pyloric column 508 is adjacentto pyloric sphincter 20.

Initially, gastroscope 82 is lubricated, inserted into patient's mouth70, and fed through esophagus 92 and GE junction 35 into stomach 30.Gastroscope 82 should ultimately be positioned such that its distal endis adjacent to pyloric sphincter 20. Preferably, a hydrophilic coatingof guidewire 84 is hydrated and inserted through gastroscope 82.Guidewire 84 is passed through pyloric sphincter 20, which may be aidedby manipulation of gastroscope 82. It may also be beneficial to pass adistal end 83 of gastroscope 82 through pyloric sphincter 20 in order tomaneuver guidewire 84 through same. There should preferably be at leastabout 30-40 centimeters of the length of guidewire 84 passed distallythrough pyloric sphincter 20 and into small intestine 40 so that anyfurther movement of guidewire 84 during the insertion procedure does notresult in the accidental removal of the distal end of guidewire 84 to aposition proximal of pyloric sphincter 20. Of course, the length ofguidewire 84 that should preferably be passed distally through pyloricsphincter 20 will vary according to different patients and/or proceduresand may be less or more than 30-40 centimeters. After guidewire 84 isappropriately positioned, gastroscope 82 is removed from the patient.Fluoroscope 96 may then be used to check the positioning of guidewire84.

As mentioned above, implant 500 should be preassembled with anynecessary implantation tools and instruments, of course taking intoaccount any differences in structure between the “top hat,” “accordion,”and “spiral” styles of implants. Implant 500, small tube 86, and mediumtube 91 are moved distally along guidewire 84 until implant 500 ispositioned to be advanced down esophagus 92. Again, it is noted thatduring this procedure care must be taken not to pull guidewire 84proximally out of small intestine 40.

Implant 500, with plug 526 disposed proximally of spiral flange 509, isthoroughly lubricated and moved distally along guidewire 84 until it isin a position to be advanced down esophagus 92. Again, it is noted thatduring this procedure care must be taken not to pull guidewire 84 out ofsmall intestine 40. Implant 500 is inserted through esophagus 92 andinto stomach 30 by pushing proximal end 97 of medium tube 91, whichpreferably includes medium tube handle 73. During insertion, spiralflange 509 may yield to the patient's tissue such that it expands intoits expanded state. This allows for a narrower diameter of spiral flange509 as it traverses esophagus 92. Implant 500 should also be advancedwithout inlet 511 and plug 526, although inlet 511 and plug 526 shouldpreferably be connected with respective first suture 523 and secondsuture 524 at this point of the insertion procedure. Hole 503 of implant500 is smaller than the outer diameter of small tube 86. Although mediumtube handle 73 is available for manipulation, the surgeon may choose toadditionally grasp medium tube 91 at a varying position along its lengththat is close to patient's mouth 70 during insertion.

Implant 500 is pushed through esophagus 92 and into stomach 30. Due tothe length of implant 500, it is likely that at least part of sleeve 502will be passed through pyloric sphincter 20 prior to the entirety ofimplant 500 being disposed within stomach 30. Further, because of thesize of implant 500, gastroscope 82 may be reinserted into stomach 30after implant 500 is inserted.

With implant 500 inserted with spiral flange 509 in its extendedposition, over-tube 88 is preferably lubricated and inserted into thepatient's mouth 70 and down esophagus 92 while being slid over smalltube 86, medium tube 91, gastroscope 82, and any additional suturesand/or implantation tools. Distal end 81 of over-tube 88 shouldpreferably be positioned in stomach 30 adjacent to spiral flange 509.

It is conceivable that over-tube 88 be inserted prior to the insertionof implant 500, though such may require implant 500 to be differentlyconfigured to fit within a more narrow inner diameter of over-tube 88.Preferably, over-tube 88 is inserted to protect esophagus 92, GEjunction 35, and other internal bodily tissue from scarring when thevarious tubes and sutures are used during implantation, actuation, andremoval of implant 500.

Inlet 511 and plug 526 are advanced along respective first suture 523and second suture 524 down esophagus 92 and into stomach 30 preferablyby pushing distally on pusher tube handle 63. A small amount of tensionin the proximal direction should be maintained with respect to firstsuture 523 and second suture 524 extending from patient's mouth 30 sothat the same remain substantially taut through esophagus 92. Afterinlet 511 and plug 526 have been inserted into stomach 30, gastroscope82 may be inserted into the stomach.

First suture 523 and fore end 527 and aft end 528 of second suture 524are held while pusher tube 59 and suture sheath 89 are advanced towardimplant 500. Resistance will notify the surgeon that plug 526 is incontact with knot 529. Pusher tube 59 is then pushed distally until knot529 passes proximally through plug 526. As knot 529 is configured topass through thru-hole 546 of plug 526 only under application of force,plug 526 is effectively secured to a location distal of knot 529. Thedistance between knot 529 and bead 530 on suture 523 should preferablybe predetermined such that plug 526 engages spiral flange 509 andsecures inlet 511 to same while forcing spiral flange 509 to maintainits contracted position.

Implant 500, in its operative state, should be substantially in itsdeployed position, with pyloric columns 508 disposed within pyloricsphincter 20. Medium tube 91 may be used to further appropriatelyposition implant 500. Over-tube 88 may be removed, or may alternativelybe left in patient during the subsequent checking of implant 500.Gastroscope 82 and/or fluoroscope 96 may be used to inspect implant 500to confirm that such is correctly assembled and positioned.

Guidewire 84, small tube 86, medium tube 91, and any other instrument ordevice are gently pulled and removed from the patient. Scissors 90 maypreferably be used to cut first suture 523 at a point proximal of knot529, wherein the proximal portion of first suture 523 may then beremoved. Second suture 524 is preferably removed by pulling either foreend 527 or aft end 528 in a proximal direction. Second suture 524 mayalternatively be cut along its length, and both fore end 527 and aft end528 pulled proximally. After all tools and devices have been removed,gastroscope 82 and/or fluoroscope 96 may preferably be used to inspectimplant 400 and to confirm correct assembly and location Gastroscope 82,fluoroscope 96, and over-tube 88 may then be removed.

The following describes a method of removing a “spiral” style implant.The steps of the above-described method with respect to the “top hat”and “accordion” styles of implants are incorporated herein to thepresent method. Of course, certain aspects of the following method maydiffer as the variations between the different embodiments of theimplants are taken into account. Over-tube 88 is lubricated and insertedthrough esophagus 92 into stomach 30. Gastroscope 82 is preferablylubricated, inserted through over-tube 88, positioned such that itsdistal end 83 is adjacent to the proximal end of implant 500. Snare 98is inserted through gastroscope 82 and oriented over one of knobs 544 oninlet 511. Snare 98 is then pulled such that bead 530 advancesproximally through spiral flange 509. It is noted that bead 530 ispreferably configured so as not to pass through spiral flange 509 unlessunder a force applied by a surgeon. Thus, inlet 511, plug 526, and firstsuture 523 remain substantially connected during removal. Gastroscope 82is removed with snare 98 such that the connection between inlet 511 andplug 526 are monitored during removal. Gastroscope 82 is reinserted withsnare 98, which is used to grasp any portion of implant 500 to aid inremoval of same. Of course, without plug 526 forcing spiral flange 509into its contracted position, spiral flange 509 is preferably grasped bysnare 98 such that spiral flange 509 moves into its extended positionduring removal. Gastroscope 82 is again removed along with implant 500.

If, instead, bead 530 does not pass proximally through spiral flange 509under application of force via snare 98, scissors 90 may be used to cutfirst suture 523 distally of knot 529. Inlet 511, plug 526, and the restof implant 500 may then be removed separately.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

1. A pyloric valve for inhibiting the flow of chyme through the pyloricregion of the gastrointestinal tract, the pyloric valve comprising: ablocking portion including a disc-shaped inlet and a helical flange, thedisc-shaped inlet having an outer circumference and a recess disposed inthe outer circumference, and the helical flange extending along alongitudinal axis and having an outer edge and at least one recessdisposed in the outer edge, the helical flange having a contractedposition defining a contracted length and a contracted diameter and anextended position defining an extended length and an extended diameter,wherein the extended length is longer than the contracted length and theextended diameter is smaller than the contracted diameter.
 2. Thepyloric valve of claim 1, wherein the recesses of the disc-shaped inletand the helical flange are axially aligned when the helical flange is inthe contracted position.
 3. The pyloric valve of claim 1, wherein thedisc-shaped inlet further includes at least one projection extendingradially from the outer circumference.
 4. The pyloric valve of claim 1,wherein the blocking portion is a proximal portion, and wherein thepyloric valve further comprises an intermediate portion and a distalportion, the intermediate portion including at least one flexible columnand a part-spherical portion, the at least one flexible column beingconnected to the proximal portion, and the part-spherical portionconnecting the at least one flexible column to the distal portion. 5.The pyloric valve of claim 4, wherein the distal portion includes asleeve.
 6. The pyloric valve of claim 5, wherein the sleeve includes atubular surface having one or more apertures.
 7. The pyloric valve ofclaim 5, wherein the sleeve includes a beveled distal end.
 8. Thepyloric valve of claim 1, wherein the pyloric valve is constructed ofsilicon.
 9. A kit comprising: the pyloric valve of claim 1; and aninsertion system including a gastroscope, a fluoroscope, a guidewire, afirst tube, a second tube larger in diameter than the first tube, and anover-tube larger in diameter than the second tube.
 10. A kit comprising:the pyloric valve of claim 1; and a removal system including agastroscope, a fluoroscope, an over-tube, and at least one of a snare, agrasper, and a pair of scissors.
 11. A method of inserting a pyloricvalve for inhibiting the flow of chyme through the pyloric region of thegastrointestinal tract, the method comprising the steps of: providing apyloric valve including a blocking portion having a disc-shaped inletand a helical flange, the disc-shaped inlet having an outercircumference and a recess disposed in the outer circumference, and thehelical flange extending along a longitudinal axis and having an outeredge and at least one recess disposed in the outer edge, the helicalflange having a contracted position defining a contracted length and acontracted diameter and an extended position defining an extended lengthand an extended diameter, wherein the extended length is longer than thecontracted length and the extended diameter is smaller than thecontracted diameter; inserting the pyloric valve through a patient'sesophagus and into the patient's stomach with the helical flange is inthe extended position; positioning the pyloric valve within thepatient's pyloric sphincter; and manipulating the helical flange fromthe extended position to the contracted position.
 12. The pyloric valveof claim 11, wherein the step of providing a pyloric valve furtherincludes the blocking portion being a proximal portion, and wherein thepyloric valve further comprises an intermediate portion and a distalportion, the intermediate portion including at least one flexiblecolumn, the distal portion including a sleeve; wherein the step ofpositioning includes positioning the intermediate portion substantiallywithin the pyloric sphincter of the patient.
 13. The method of claim 11,wherein the step of manipulating includes forcing the disc-shaped inletagainst the helical flange.